CN101404966B - Surgical wound dressing - Google Patents

Surgical wound dressing Download PDF

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Publication number
CN101404966B
CN101404966B CN 200780009481 CN200780009481A CN101404966B CN 101404966 B CN101404966 B CN 101404966B CN 200780009481 CN200780009481 CN 200780009481 CN 200780009481 A CN200780009481 A CN 200780009481A CN 101404966 B CN101404966 B CN 101404966B
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CN
China
Prior art keywords
wound
beads
wound dressing
ro
dressing system
Prior art date
Application number
CN 200780009481
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Chinese (zh)
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CN101404966A (en
Inventor
S·马利根
Original Assignee
泰科保健集团有限合伙公司
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Priority to US76592106P priority Critical
Priority to US60/765,921 priority
Application filed by 泰科保健集团有限合伙公司 filed Critical 泰科保健集团有限合伙公司
Priority to PCT/US2007/003079 priority patent/WO2007092405A2/en
Publication of CN101404966A publication Critical patent/CN101404966A/en
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Publication of CN101404966B publication Critical patent/CN101404966B/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive plasters or dressings
    • A61F13/0203Adhesive plasters or dressings having a fluid handling member
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive plasters or dressings
    • A61F13/023Adhesive plasters or dressings wound covering film layers without a fluid handling layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/008Drainage tubes; Aspiration tips
    • A61M1/0088Drainage tubes; Aspiration tips with a seal, e.g. to stick around a wound for isolating the treatment area
    • CCHEMISTRY; METALLURGY
    • C03GLASS; MINERAL OR SLAG WOOL
    • C03CCHEMICAL COMPOSITION OF GLASSES, GLAZES, OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
    • C03C12/00Powdered glass; Bead compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00365Plasters use
    • A61F2013/00536Plasters use for draining or irrigating wounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00365Plasters use
    • A61F2013/0054Plasters use for deep wounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/15Detection of leaks

Abstract

A operation wound dressing system includes a fluid permeable support member for positioning within a wound and adapted to generally conform to a topography of a wound, a plurality of beads supported by the support member, an outer member for positioning over the wound to substantially enclose the beads and a conduit for supplying reduced pressure to the wound. The support member is adapted to permit exudates from the wound to pass therethrough. The beads are characterized by having sufficient rigidity to substantially maintain respective shapes thereof to thereby facilitate passage of the exudates through spaces or passages defined between adjacent beads. The beads may comprise glass, an acrylic or a polymeric material. The support member may comprise a polymeric or fabric material. The support member may be an enclosure member or pouch which houses the beads. Multiple pouches are also envisioned.

Description

手术伤ロ敷料 Surgical wound dressing ro

[0001] 相关申请的交叉引用 CROSS [0001] REFERENCE TO RELATED APPLICATIONS

[0002] 本申请要求2006年2月7日提交的、名称为“手术伤ロ敷料”、序列号为60/765,921的临时申请的权益,所述申请的全部内容引用于此作为參考。 [0002] This application claims the February 7, 2006, filed, entitled "Surgical wound dressing ro" for the benefit of Provisional Application Serial Number 60 / 765,921, the entire contents of which are incorporated herein by reference.

技术领域 FIELD

[0003] 本公开涉及一种用于处理开放性伤ロ的装置,更具体而言涉及ー种用于负压治疗的伤ロ敷料系统。 [0003] The present disclosure relates to an apparatus for processing ro open wounds, and more particularly to vacuum wound therapy for the species ー ro dressing system.

背景技术 Background technique

[0004] 伤ロ闭合涉及邻近伤ロ的上皮和皮下组织朝着伤ロ的中心迁移直到伤ロ闭合。 [0004] relates to wound closure adjacent the wound ro ro epithelial and subcutaneous tissue migrate toward the center of the wound until the wound ro ro closed. 不幸的是,大伤ロ或感染的伤ロ难以闭合。 Unfortunately, major injuries or ro ro infected wounds difficult to close. 在这样的伤ロ中,在伤ロ的表面附近形成郁滞区(即组织的局部肿胀限制血液流到组织的区域)。 In such a wound ro in the vicinity of the surface is formed stagnation zone ro injury (i.e., tissue swelling of tissue blood flow restricted areas). 没有足够的血流,围绕伤ロ的上皮和皮下组织不仅接收的氧气和营养物減少,而且不太能够成功地抵御微生物感染,因此不太能够自然地闭合伤ロ。 There is not enough blood around the injury ro epithelial and subcutaneous tissue receives not only reduce oxygen and nutrients, and are less able to successfully resist microbial infection, and therefore less able to naturally close wounds ro. 这样的伤ロ多年来困扰着医务人员。 Such a ro hurt for years plagued the medical staff.

[0005] 伤ロ敷料在医学行业中用于保护和/或便于开放性伤ロ的愈合。 [0005] ro wound dressings to protect and / or facilitate healing of open wounds ro in the medical industry. 一种技术已经使用了负压治疗(也被称为抽吸或真空治疗)。 One technique has been used negative pressure therapy (also referred to as suction or vacuum therapy). 开发了各种负压装置以允许去除过多的伤ロ流体,即渗出物,同时隔离伤ロ以保护伤ロ,因此影响恢复时间。 A negative pressure developed various means to allow removal of excess wound fluid ro, i.e., exudates, while isolating the wound to protect the wound ro ro, thus affecting the recovery time. 各种伤ロ敷料被改良以促进开放性伤ロ的愈合。 Various injuries ro dressings are modified to promote healing of open wounds ro.

[0006] 当在负压治疗中使用伤ロ敷料时需要继续解决的问题包括使用的容易性、治愈伤ロ的效率以及伤ロ渗出物的充分引流。 Adequate drainage problem [0006] When used in negative pressure wound therapy dressing ro need to continue to address include ease of use, efficiency, and heal wounds ro ro wound exudate. 因此,仍然需要一直提高用于开放性伤ロ的负压伤ロ敷料。 Thus, there remains a need to increase the negative pressure has been open wound dressing ro ro injuries.

发明内容 SUMMARY

[0007]因此,本公开涉及一种伤ロ敷料系统,该伤ロ敷料系统包括:可透流体的支撑元件,其用于定位在伤口内并且适于适应伤ロ的形态;多个微珠,其由所述支撑元件支撑;夕卜部元件,其用于定位在伤口上以基本封闭所述微珠;和管道,其用于将减小的压カ供给伤ロ。 [0007] Accordingly, the present disclosure relates to a wound dressing system ro, ro the wound dressing system comprising: a fluid permeable support element, for positioning within the wound and adapted to accommodate injury ro form; a plurality of beads, supported by the support member; Bu Xi element portion for positioning over a wound to substantially enclose the beads; and conduit means for feeding reduced pressure ka ro injury. 所述支撑元件适于允许来自伤ロ的渗出物通过其中。 The support member is adapted to allow the exudate from the wound ro therethrough. 所述微珠的特征在于具有足够的刚性以基本保持它们各自的形状,由此便于渗出物通过相邻微珠之间限定的空隙或通道。 Wherein the beads have sufficient rigidity to substantially retain their respective shapes, thereby facilitating exudates from passing through the gap defined between adjacent beads or channels. 所述微珠可以包括玻璃、丙烯酸酯(acrylic)或聚合材料。 The beads may comprise glass, acrylic (Acrylic) or a polymeric material. 所述微珠中的至少ー些可以包括药剂的外层。ー least some of the medicament may comprise the outer layer of microbeads. 可供选择地,所述微珠中的至少ー些可以包括通过其中的孔以允许渗出物的通过。 Alternatively, the beads least ー These may include an aperture therethrough to allow exudates. 药剂可以布置在这些微珠的孔内。 Agent may be disposed within the bore of the beads. 在一个实施例中,沿细长或线状元件连接所述微珠。 In one embodiment, the beads along the elongated element or wire connection. 在另ー实施例中,所述微珠被粘结或安装到所述支撑元件。ー In another embodiment, the beads are bonded or mounted to the support member. 所述微珠可以是可吸收的或不可吸收的。 The beads may be absorbable or non-absorbable. 如果由可吸收材料制造,所述微珠的吸收速度可以被控制、预先选择等等,从而在足以提供通过微珠布置便于引流滲出物的沟道的时间段保持所述微珠的完整性。 If the beads may be controlled by the rate of absorption of the absorbent material may be selected in advance, etc., so that a time period sufficient to provide a drainage channel exudates maintain the integrity of the beads by the bead arrangement to facilitate. 所述微珠可以进一歩能够吸收ー些渗出物。 The beads may be capable of absorbing into a ho ー some exudate. 所述微珠可以定期地从伤ロ区域被去除并且用新的微珠更换。 The beads can be periodically removed from the area of ​​injury and replaced with a new ro microbeads. 可供选择地,所述微珠可以适于在整个愈合过程期间保留。 Alternatively, the beads may be adapted to retain during the entire healing process. [0008] 所述支撑元件可以包括聚合或织物材料。 [0008] The support member may comprise a fabric or polymeric material. 所述支撑元件可以是容納所述微珠的封闭元件或囊袋。 The support member may be a closure member receiving the beads or bladder. 还可以想到多个囊袋。 It is also conceivable multiple pockets. 所述外部元件适于形成围绕伤ロ的基本不透液体的密封件。 The outer element is adapted to form a seal around the wound ro substantially liquid impermeable. 所述外部元件可以包括半透性材料。 The outer member may comprise a semipermeable material.

[0009] 负压源与所述管道流体连通。 [0009] negative pressure source in fluid communication with the conduit. 所述负压源包括真空泵。 The negative pressure source comprises a vacuum pump.

[0010] 在另ー实施例中,所述伤ロ敷料系统包括:可透流体的封闭囊袋,其用于定位在伤口内并且适于允许来自伤ロ的渗出物通过其中;多个微珠,其布置在所述封闭囊袋内;夕卜部元件,其适于定位在伤口上以基本封闭所述微珠;和负压装置,其用于将减小的压カ供给伤ロ。 [0010] In another embodiment ー embodiment, the wound dressing ro system comprising: a fluid permeable closed pouch for positioning within the wound and adapted to allow the exudate from the wound ro therethrough; a plurality of micro beads disposed in the closed sachet; Xi Bu section member adapted to be positioned over a wound to substantially enclose the beads; and vacuum means for reducing the pressure supplied ka ro injury. 所述微珠具有足够的刚性以基本保持它们各自的形状,由此便于渗出物通过相邻微珠之间限定的空隙。 The beads have sufficient rigidity to substantially retain their respective shapes, thereby facilitating exudates from passing through the gap defined between the adjacent beads.

[0011] 在另ー优选实施例中,所述伤ロ敷料系统包括:框架,其尺寸设定成用于定位在伤ロ创面(wound bed)内并且具有限定间隔小室的一系列互连壁;外部元件,其适于定位在伤口上并且适于形成围绕伤ロ的不透液体的密封件;和管道,其用于将减小的压カ供给伤ロ创面。 [0011] In another embodiment ー preferred embodiment, the wound dressing ro system comprising: a frame, which is dimensioned for location ro wound injury (wound bed) and having an inner chamber defining a series of spaced interconnecting wall; outer member, adapted to be positioned over the wound and adapted to form a liquid tight seal around the wound ro; and conduit means for feeding reduced pressure ka ro wound injury. 所述小室具有足够的刚性以在减小的压カ下基本保持它们的初始构造,并且具有开ロ,所述开ロ尺寸设定成允许伤ロ渗出物通过其中。 Said chamber having sufficient rigidity to under reduced pressure ka substantially maintain their original configuration, and has an open ro, said opening sized to allow ro ro wound exudate therethrough. 所述小室中的至少ー个限定基本为多边形的形状,例如三角形、正方形或六边形,或者可以是弓形。 The chamber in at least one defined ー substantially polygonal shapes such as triangular, square or hexagonal, or may be arcuate. 所述框架优选地包括硅。 The frame preferably comprises silicon.

附图说明 BRIEF DESCRIPTION

[0012] 在这里參考附图描述了本公开的伤ロ敷料系统的各种实施例: [0012] where the various figures of the present disclosure described wound dressing system ro Reference Example:

[0013] 图I是示出伤ロ敷料和负压源的本公开的伤ロ敷料系统的侧视图; [0013] Figure I is a side view of the wound dressing system according ro the present disclosure ro wound dressing and the negative pressure source;

[0014] 图2是用于图I系统的伤ロ敷料的微珠的一个实施例的侧视横截面图; [0014] FIG. 2 is a diagram for wound dressing ro I system microbeads a side cross-sectional view of an embodiment;

[0015] 图3是用于图I系统的伤ロ敷料的微珠的另ー实施例的侧视横截面图; [0015] FIG. 3 is a diagram for wound dressing ro I system microbeads ー another side cross-sectional view of an embodiment;

[0016]图4是图I系统的伤ロ敷料和带有泡沫的现有技术敷料的负压或泵组压力作为时间函数的图形表示; [0016] FIG. 4 is a diagram of the system I ro wound dressing and the negative pressure pump or the prior art dressing having a foam as a graphic representation of a function of time;

[0017]图5A和5B是在通过图I系统的伤ロ敷料和现有技术的纱布和泡沫敷料的敷料厚度的任何点获得的负压水平的图形表示; [0017] FIGS. 5A and 5B is the negative pressure level at any point ro gauze and foam dressings and wound by the prior art system of FIG. I dressing the dressing to obtain a graphical representation of the thickness;

[0018] 图6是图I系统的伤ロ敷料和现有技术泡沫敷料的在干性伤ロ的伤ロ部位的压カ分布图的图形表不; [0018] FIG. 6 is a prior art wound dressings and ro foam dressing in a pressurized dry wound injury ro ro ka site distribution pattern table of FIG. I system does not;

[0019]图7是图I系统的伤ロ敷料和现有技术泡沫敷料的在湿性伤ロ的伤ロ部位的压カ分布图的图形表不; [0019] FIG. 7 is a wound dressing of FIG ro I system and the prior art wet foam dressing in the wound pressure ro ro injury site distribution pattern table of FIG ka not;

[0020] 图8A和SB是图I系统的隧穿伤ロ敷料和现有技术泡沫敷料的真空水平的图形表示; [0020] FIGS. 8A and SB is a graphical ro prior art foam dressing and the dressing of the level of vacuum tunneling through the system of FIG. I represents injury;

[0021] 图9是示出用于图I系统的伤ロ敷料的大和小微珠的真空水平和时间的关系的图示; [0021] FIG. 9 is a diagram showing the relationship between wound dressing Japanese ro vacuum level and the small beads of time for the system of FIG. I;

[0022]图10是图I系统的伤ロ敷料的一个可供选择的实施例的侧视图,所述敷料包含采用容纳微珠的封闭元件形式的支撑元件; [0022] FIG. 10 is a side view of an alternative embodiment of a wound dressing of FIG ro of the I system, the dressing comprises a support member in the form of closure member using the receiving beads;

[0023] 图11是图I系统的伤ロ敷料的另一可供选择的实施例的侧视图,示出用于容纳微珠的多个封闭元件; [0023] FIG. 11 is a side view of another alternative embodiment of the system of FIG. I ro wound dressing, shown for receiving a plurality of beads closure element;

[0024] 图12是图I系统的ー个可供选择的实施例的视图,示出沿互连元件附连的伤ロ敷料的微珠;[0025] 图13是示出定位在伤ロ创面内的图I系统的另一实施例的视图; [0024] FIG. 12 is a view of the system of Figure I embodiment ー one alternative, shown along the interconnection elements attached ro wound dressing beads; [0025] FIG. 13 is a diagram illustrating the positioning wound injury ro view of another embodiment of the system of Figure I in the embodiment;

[0026] 图14和15分别是图13系统的支撑片材的顶视和侧视图,示出安装到支撑片材的微珠;和 [0026] FIGS. 14 and 15 are top and side views of the supporting sheet of FIG. 13 system, shown mounted to the support beads sheet; and

[0027]图16是图I系统的又一实施例的视图,该系统包含在伤ロ敷料内的网格框架基质。 [0027] FIG. 16 is a view of still another embodiment of the system of Figure I embodiment, the system comprises a grid frame in the ro wound dressing within the matrix.

具体实施方式 Detailed ways

[0028] 本公开的伤ロ敷料系统与负压治疗结合促进伤ロ的愈合。 [0028] The present disclosure in combination with the negative pressure wound treatment dressing system according ro promote wound healing ro. 所述系统的ー个优选伤ロ敷料包括由支撑层支撑的多个微珠。 The preferred system ー wound dressing comprising a plurality of microbeads ro supported by a support layer. 所述微珠适应于伤ロ的形状,同时允许空气和渗出物流过敷料,由此促进潮湿环境并便于伤ロ的愈合。 Ro the beads is adapted to the shape of wound, exudate while allowing air to flow through the dressing and thereby facilitate and promote moist wound environment ro healing.

[0029] 现在參考图I,示出本公开的伤ロ敷料系统100的ー个优选实施例。 [0029] Referring now to Figure I, ro wound dressing system shown ー preferred embodiments of the present disclosure 100. 伤ロ敷料系统100包括伤ロ敷料102和通过管道与伤ロ敷料102流体连通的负压装置或负压源104,所述管道示意性地由附图标记106表示。 Wound dressing system 100 includes a wound ro ro ro negative pressure dressing 102 and the negative pressure source 104, or dressing means in fluid communication via conduit 102 with injury, the conduit is schematically represented by reference numeral 106. 伤ロ敷料102包括几个部件,即支撑层或支撑元件108、由支撑元件108支撑的多个微珠110以及外层或覆盖元件112。 Ro wound dressing 102 includes several components, i.e., the support layer or the support member 108, supported by the support member 108 or the plural beads 110 and an outer cover member 112.

[0030] 支撑元件108适于基本适应于伤ロ创面“w”的形态(topography)。 [0030] The support member 108 is adapted to substantially conform to the wound injury ro "w" morphology (topography). 支撑元件108是基本多孔的以允许渗出物从伤ロ创面“w”穿过支撑元件108。 The support member 108 is substantially porous to permit exudates from wounds ro wound "w" through the support member 108. 这里使用的“多孔”指的是包含许多小穿孔或微孔的材料,所述小穿孔或微孔允许各种类型的伤ロ流体穿过所述材料。 As used herein, "porous" refers contains many small perforations or a microporous material, said small perforations or microporous injury allowed ro types of fluid through the material. 支撑元件108还可以是非粘连的。 Support member 108 may also be non-adherent. 这里使用的“非粘连”指的是不粘连到在伤ロ创面中和周围的组织的材料。 As used herein, "non-blocking" refers to a non-stick material and surrounding tissue in the wound ro wounds. 该构造允许流体和渗出物不受约束地穿过支撑元件108,并且支撑元件108最小限度地“粘附”到伤ロ创面“W”。 This configuration allows fluid and exudates uninhibited through the support member 108, the support member 108 and minimal "stick" to the wound ro wound "W is."

[0031] 伤ロ渗出物通过支撑元件108优选是单向的,使得伤ロ渗出物不会流回到伤ロ创面“W”。 [0031] ro wound exudate through the support member 108 is preferably unidirectional such that wound exudates do not flow back ro ro injury wound "W". 该单向流动特征可以采用以下形式:设在材料层中的定向开孔、不同吸收性的材料层压到支撑元件108或促进定向流动的特定材料选择。 This unidirectional flow feature may take the form: provided in the material layer directed openings, a different absorbent material laminated to the support element 108 a particular choice of material or promote directional flow. 然而,还可想到用于将药物或抗感染剂供给伤ロ创面“w”的双向层,其后将对其进行描述。 However, also conceivable for supplying bidirectional ro wound layer wound "w" of the drug or anti-infective agents, which will be described subsequently.

[0032] 另外,诸如水凝胶和药剂这样的试剂可以粘合或涂覆到支撑元件108以减小伤ロ中的生物负担、促进愈合并减小与敷料更换或去除相关的疼痛。 [0032] Further, such agents as hydrogels and medicaments may be bonded or coated to the support member 108 to reduce bioburden in the wound ro, promote healing and reduce or remove dressing changes associated with pain. 药剂例如包括抗菌剂、生长因子、抗生素、止痛剂、清创剂等。 Antibacterial agents include, for example, growth factors, antibiotics, analgesics, debridement agents and the like. 此外,当使用止痛剂时,止痛剂可以包括允许在敷料去除或更换之前释放所述试剂的机制。 Further, when the use of analgesics, analgesic agents may include mechanisms allow removal or replacement of the release agent prior to dressing.

[0033] 支撑元件108可以由各种不同的材料构造。 [0033] The support member 108 may be constructed from a variety of different materials. 这些材料可以包括但不限于不可吸收的合成聚合纤维,例如碳化聚合物、聚こ烯(PET)、聚丙烯(PP)、聚四氟こ烯(PTFE)、尼龙、芳酰亚胺(arimids)、凯芙拉(Kevlar)、聚对苯ニ甲酸こ酯(PET),或天然纤维,例如纤维素。 These materials may include, but are not limited to, synthetic polymeric fibers absorption, for example carbonized polymers, ko-ene (PET), polypropylene (PP), polytetrafluoroethylene ko-ene (PTFE), nylon, aromatic polyimide (arimids) , Kevlar (of Kevlar), polyparaphenylene ni ko acid ester (PET), or natural fibers such as cellulose. 可以想到的是,支撑元件108可以是透明的以允许提高可视性和更佳地观察伤ロ创面“ W”。 It is contemplated that the support member 108 may be transparent to allow improved visibility and better observed injury ro wound "W". 而且,支撑元件108可以由织物构造,所述织物可以是机织、无纺(包括熔喷)、针织或复合结构,例如纺粘织物。 Further, the support member 108 may be, the woven fabric may be constructed from a textile, nonwoven (including meltblown), knitted or composite structures such as spunbonded fabric. 用作支撑元件108的典型材料在商标EXCIL0N™下由TycoHealthcare 下属的Kendall Corp 公司销售。 Typical materials for the support member 108 under the trademark EXCIL0N ™ by a subsidiary of TycoHealthcare Kendall Corp sales.

[0034] 再次參考图1,现在将论述微珠110。 [0034] Referring again to FIG. 1, beads 110 will now be discussed. 微珠110优选地是基本刚性的,以在愈合期间在至少一段预定时间段保持它们的形状。 Beads 110 are preferably substantially rigid to retain their shape at least a predetermined period of time during healing. 在这方面,当布置在伤ロ创面“内时微珠110在其间限定空隙或通道114,以允许伤ロ渗出物穿过通道114。微珠110的尺寸可以变化,但是它们的尺寸应当设定成获得通过微珠布置的适当的小孔尺寸,以便于细胞增殖并且允许流体和空气从伤ロ排空。已经发现范围在10-1000 um的孔隙度在刺激细胞增殖和允许流体和空气从伤ロ排空方面是有益的。微珠110与支撑元件108结合工作以适应伤ロ创面“w”,同时允许从伤ロ创面“w”引流伤ロ渗出物和释放空气而不堵塞。当施加负压时,微珠110将移动并且重新调整它们各自的位置以防止目前的泡沫设计可能发生的疼痛的向内生长。 In this regard, when the wound is disposed in the wound ro "When the bead 110 defines a void or channel 114 therebetween to permit wound exudates from passing through ro dimensions of the channel 114. The beads 110 may vary, but their size should be provided set to obtain an appropriate pore size beads by arrangement to facilitate cell proliferation and allow fluid and air is evacuated from the wound ro has been found that the porosity in the range of 10-1000 um in stimulating cell proliferation and allow fluid and air from ro injury is beneficial in terms emptying. beads 110 work in conjunction with the support member 108 to accommodate the wound ro wound "w", while allowing the wound ro wound "w" ro draining wound exudates and release of air without clogging. when negative pressure is applied, the beads will move and 110 readjust their respective positions to prevent painful ingrowth current bubble design may occur.

[0035] 微珠110由合适的生物相容材料制造。 [0035] 110 beads manufactured from a suitable biocompatible material. 微珠110可以是抗微生物微珠,带有生长因子、药剂、抗生素、止痛剂以及例如维生素、营养物等的愈合因子的微珠。 Beads 110 may be an antimicrobial microbeads, microbeads with healing factors growth factors, medicaments, antibiotics, and analgesics such as vitamins, nutrients and the like. 这些微珠110优选地是非粘连的,并且可以在一段预定时间段是生物可吸收的。 These beads 110 are preferably non-blocking, and may be bioabsorbable at a predetermined time period. 丙烯酸酯(PMMA)可以由于它的透明性而被使用并且还向临床医生提供了看到伤ロ而不用去除敷料的性能。 Methacrylate (PMMA) because of its transparency can be used and also provides a wound ro seen without removing the dressing performance of the clinician. 可以使用的其它材料是聚碳酸酷、聚苯こ烯、PVC、ABS、SAN、玻璃或硅树脂。 Other materials may be used to cool a polycarbonate, polyphenylene ko alkenyl, PVC, ABS, SAN, glass or silicon resin. 还可以使用生物可吸收的聚合物,例如聚交酯(PLA)、聚こ交酯(PGA)、壳聚糖、聚环氧こ烷(PEO)或聚こニ醇(PEG)。 May also be used bioabsorbable polymers, such as polylactide (PLA), poly ko lactide (PGA), chitosan, polyalkylene oxide alkyl ko (PEO), or poly alcohol ko ni (PEG).

[0036] 微珠110优选地在愈合期间在至少一段预定时间段是基本刚性的以保持预期间隔,由此限定通过创面的微珠的通道114以用于通过伤ロ渗出物、空气等。 [0036] The bead 110 is preferably at least during the healing period of the predetermined time period is substantially rigid to maintain the desired intervals, thereby defining a passageway 114 through the beads for ro wound exudate, such as air through the injury. 因此,微珠110可以是不可吸收的。 Thus, the beads 110 may be non-absorbable. 可供选择地,微珠110和微珠尺寸可以是部分或完全可吸收的。 Alternatively, bead 110 and bead sizes may be partially or completely absorbable. 使用可吸收的材料,可以选择微珠110的吸收速度以在预定愈合期间保持预期刚性。 Use of the absorbent material, the absorption rate may be selected to maintain the desired beads 110 during a predetermined rigidity healing. 本领域的技术人员可以选择微珠110的制造材料以达到这些目的。 Those skilled in the art can select a material for producing beads 110 to achieve these objectives. 微珠110的溶解速度取决于材料选择、微珠尺寸(与流体接触的微珠的表面积)、伤ロ创面中的流体量和温度。 Dissolution rate of the beads 110 depends on the material selected, the size of the beads (the surface area in contact with the fluid beads), ro wound fluid amount and temperature of the wound. 微珠110中的ー些或全部可以设计成在敷料在患者身体上保持就位(I天至I周)的全部时间保持刚性。 The beads 110 ー some or all may be designed to remain rigid at all times to maintain the dressing in place on the body of the patient (I I days to weeks). 这将保持空气和流体从伤ロ流动。 This will keep the flow of air and fluid from the wound ro. 微珠110中的一些可以设计成在该时间段,I天至I周溶解,从而释放包含在微珠110中的任何活性成份。 Some of the beads 110 may be designed to the time period, I I days to weeks to dissolve, thereby releasing any active ingredient contained in the beads 110. 微珠110的附加溶解可以被定时以适应计划的敷料更换,从而当去除敷料时防止组织生长到微珠中和导致创伤。 Additional beads were dissolved 110 may be timed to replace the dressing adaptation program, so as to prevent tissue growth and leads to microbeads trauma when the dressing is removed.

[0037] 还可以想到微珠110的多种变化。 [0037] It is also contemplated that various changes beads 110. 例如,微珠110可以进一歩包括如图2中所示的药物层116,所述药物层构造用于将药剂分布到伤ロ创面“w”中。 For example, the beads 110 may comprise FIG ho into a drug layer 116 shown in FIG. 2, the drug layer is configured to distribute the agent ro injury wound "w" in. 药物层116可以包含与支撑元件108的论述有关的上文所述的任何药剂。 Drug layer 116 may comprise any agent of the above discussion relating to the support member 108. 这些药剂优选地以预期速度释放到伤ロ创面“w”中,以优化愈合和/或减小疼痛。 These agents are preferably released at a desired rate ro injury to the wound "w" in order to optimize the healing and / or reduce pain. 可供选择地,如图3中所示,微珠110可以是多孔的,包括中心孔118,由此提供伤ロ渗出物的附加通道和/或伤ロ部位周围空气的循环。 Alternatively, as shown in FIG. 3, the beads 110 may be porous, includes a central bore 118, thereby providing an additional circulation path and wound exudates ro / ro injury site or ambient air. 还可以想到的是,这些孔118可以包含生物可吸收的材料,例如抗菌剂、抗感染剂或其它药齐U。 It is also conceivable that the holes 118 may comprise a bioabsorbable material, for example, antimicrobials, anti-infective agents, or other agents flush U. 一旦药剂被吸收进伤ロ创面“w”中,微孔118保持,并且便于空气和伤ロ渗出物的流动。 Once the drug is absorbed into the wound ro wound "w", the microporous 118 holder, and facilitate the flow of air and wound exudates ro.

[0038] 再次參考图1,外部元件112包围伤ロ敷料100的周边,以围绕伤ロ创面“ w”并提供围绕伤ロ创面“的周边“P”的密封件。例如,密封机构可以是粘合到围绕伤ロ创面“w”的层的任何粘合剤。所述粘合剂必须提供与围绕伤ロ创面“W”的组织,例如伤ロ周围区域的可接受粘合,并且用在皮肤上是可接受的而不会有接触恶化(例如粘合剂应当优选地是非刺激性的和非致敏性的)。所述粘合剂可以是可渗透的以允许所接触的皮肤透气和传输湿气。另外,所述粘合剂可以通过外部刺激例如加热或指定流体溶解或化学反应被激活或去活。粘合剂例如包括医用级丙烯酸酯,例如用于TycoHealthcare Group,LP的CURAF0AMISLAND™的粘合剂,或者是皮肤友好的和非刺激性的任何硅树脂或橡胶基医用粘合剤。外部元件112可以设有粘合剂衬底和/或可供选择地,粘合剂可以在操作 [0038] Referring again to FIG. 1, the outer member 112 surrounding the wound ro periphery of dressing 100 to surround wound ro wound "w" and provide a "perimeter" P "seal around the wound ro wound. For example, the sealing means may be glued any adhesive bonded to Ji ro wound around the wound "w" of the layer. the adhesive must provide ro wound around the wound "W" of tissue, for example, wound around ro acceptable adhesive area, and is used in the skin the contacting is acceptable without the deterioration (e.g., non-sensitizing and adhesive should preferably be non-irritating to). the adhesive may be permeable to permit the contacted skin permeability and transmission moisture. Further, the adhesive may be heated by an external stimulus, for example, or dissolution or chemical reaction fluid designated to be activated or deactivated. for example comprises a medical grade adhesive acrylates, for example TycoHealthcare Group, LP of the CURAF0AMISLAND ™ adhesive, or a skin-friendly and non-irritating to any silicone or rubber based medical adhesive Ji outer member 112 may be provided with an adhesive substrate and / or alternatively, the adhesive may in operation 间施加于外部元件112和/或皮肤。 Applied between the outer member 112 and / or skin.

[0039] 外部元件112典型地是密封伤ロ敷料100的顶部的柔性材料,例如弹性或弾性体材料。 [0039] The external sealing member 112 is typically a flexible material wound dressing ro top 100, for example, of an elastic material or a Tan. 典型的柔性材料包括在商标Polyskin II下由TycOHealthcare Group LP下属的Kendall Corp公司制造的透明敷料。 Typical flexible material comprises a transparent dressing under the trademark Polyskin II under the TycOHealthcare Group LP manufactured by Kendall Corp. 优选地,外部元件112是透明的并且提供微生物和流体污染物的屏障。 Preferably, the outer member 112 is transparent and provide a barrier to microbes and fluid contaminants. 外部元件112可以由可渗透塑料薄膜制造,所述薄膜为它提供高湿汽传输速度(MVTR)以允许渗出物通过薄膜。 Outer member 112 may be, the film provides high wet vapor transmission rate (the MVTR) to allow exudates from passing through the permeable film is a plastic film made from it. 这样的薄膜可以由聚氨酯、透气性聚烯烃或共聚多酷制造。 Such film may be made of polyurethane, copolyester or breathable polyolefin manufactured cool. 外部元件112的透明性允许伤ロ敷料,尤其是伤ロ自身的状态的视觉检查。 Transparency of the outer member 112 allows ro wound dressing, in particular wound itself ro visual inspection status. 可供选择地,外部元件112可以是不透湿汽的。 Alternatively, the outer member 112 may be impermeable to moisture vapor.

[0040] 外部元件112可以包括出入门(未示出)以提供对伤ロ敷料102的内部和/或伤ロ创面“w”的接近。 [0040] The outer member 112 may include an access door (not shown) to provide access to the internal injury and ro / ro injury or wound "w" dressing 102. 所述门可以是与外部元件112—体形成的翼片或通过铰链或类似物连接到外部元件112的独立部件。 The door flaps may be formed with an external element 112- or a separate component connected to outer member 112 by a hinge or the like. 所述门可以是可再密封的以保持伤ロ敷料102的完整性并提供相对于外部元件112的气密密封。 The door may be resealable to maintain the integrity of the wound dressing 102 and ro provide a hermetic seal with respect to the outer member 112. 所述门优选地提供对伤ロ创面“w”的接近以允许临床医生监视伤ロ的状态,调节、増加或去除微珠110,或在需要时将附加医疗处理,例如生长因子、清创剂或其它伤ロ愈合试剂施加于伤ロ。 The door closer is preferably provided to enable the clinician to monitor the status of injury ro, adjustment, or removal of beads 110 to increase in, or if necessary additional medical treatment, such as growth factors, wound debriding agent ro wound "w" in or other wound healing agent is applied to the wound ro ro.

[0041] 再次參考图1,负压源104通过管道106将真空施加到伤ロ。 [0041] Referring again to FIG. 1, the negative pressure source 104 through conduit 106 a vacuum is applied to the wound ro. 在一个实施例中,手动泵用作负压源。 In one embodiment, a manual pump as the negative pressure source. 一种合适的手动泵在授予Gross的共同转让美国专利No. 5,549,584中被公开,所述专利的全部内容被引用于此作为參考。 A suitable manual pump is disclosed in commonly assigned issued to Gross U.S. Patent No. 5,549,584, the entire contents of which are incorporated herein by reference. 可供选择地,可以利用自动泵。 Alternatively, you can use an automatic pump. 典型地,在伤ロ“ w”内由负压源104产生的负压的范围为大约20mmHg至大约500mmHg,更优选地为大约75mmHg至大约125mmHg。 Typically, the negative pressure in the range ro wound "w" generated by the negative pressure source 104 is from about 20mmHg to about 500 mmHg, more preferably from about 75mmHg to about 125mmHg. 自动泵可以采用壁抽吸形式,例如在急性或亚急性病症监护设施中可用的那些自动泵。 Automatic walls of the suction pump may take the form, such as those available in the automatic pump acute or subacute care facilities disorders. 自动泵可以采用便携式泵的形式。 Automatic pump may take the form of a portable pump. 便携式泵可以采用小型或微型泵的形式,其保持或抽吸足够的和治疗性的真空水平。 The portable pump may be employed in the form of mini or micro pump, or a suction that holds a sufficient vacuum level and therapeutic. 在一个优选实施例中,所述泵是便携式的、轻质的、电池操作的抽吸泵,该泵附连到管系的近端。 In a preferred embodiment, the pump is portable, lightweight, battery operated suction pump, the pump is attached to the proximal end of the tubing. 典型地,负压源104具有调节装置以施加用于愈合伤ロ的最佳真空压カ。 Typically, the negative pressure source 104 has an adjustment means to apply a vacuum pressure grades for optimal healing of wounds ro. 此外,如果未获得最佳真空压カ,负压源104优选地将包含用于检测系统中的泄漏的机构。 Further, if the vacuum pressure is not the best grades, the negative pressure source 104 preferably comprises a means for leak detection system of. 优选地,负压源104还将包含指示器(未示出)或传感器以检测伤ロ或伤ロ敷料内的压力。 Preferably, negative pressure source 104 also comprises an indicator (not shown) or a sensor for detecting damage or injury ro ro pressure within the dressing. 蠕动泵可以用作负压源104。 The peristaltic pump 104 may be used as a source of negative pressure. 典型的蠕动泵包括多个辊,所述辊沿圆形路径由电动机(或其它合适的原动机)沿旋转方向驱动。 A typical peristaltic pump comprises a plurality of rollers, said rollers driven by a motor (or other suitable prime mover) in a rotational direction along a circular path. 在多数这样的蠕动泵中常见的是,辊定期地接触和挤压管系,并且当所述辊沿圆形路径移动时,连续的气泡通过用于从伤ロ抽吸渗出物的管系被抽吸。 Common in most such peristaltic pumps is that the contact roller and periodically squeeze the tubing, and when the roller moves along a circular path for continuous bubbles by the suction from the wound exudate ro tubing It is drawn. 优选地,蠕动泵以50cc每分钟的速度将大约125mmHg输送到伤ロ创面。 Preferably, a peristaltic pump to transport wound about 125mmHg ro wound at a rate of 50cc per minute.

[0042] 在优选实施例中,管道106采用柔性管系的形式并且与真空连接器120流体连通。 [0042] embodiment, the conduit 106 in the form of flexible tubing and in fluid communication with the vacuum connector 120 in the preferred embodiment. 真空连接器120安装到伤ロ敷料102。 Vacuum connector 120 is mounted to the wound dressing 102 ro. 真空连接器120可以通过粘合剂或类似物被固定到外部元件112的外表面,或者可供选择地,可以至少部分地置于外部元件112中的开ロ122内并且固定到开ロ122内。 Vacuum connector 120 may be secured by adhesive or the like to the outer surface of the outer member 112, or alternatively, may be at least partially disposed within the outer member 112 and fixed to the opening 122 ro ro the opening 122 . 真空连接器120可以在手术部位施加到伤ロ敷料102或者可以预先连接到伤ロ敷料102。 Vacuum may be applied to the connector 120 ro wound dressing 102 or may be pre-attached to the wound dressing 102 at the surgical site ro. 可供选择地,伤ロ敷料102可以没有真空连接器122,由此管道106将直接接近伤ロ敷料102的内部。 Alternatively, the wound dressing 102 may not have ro vacuum connector 122, conduit 106 to thereby direct access to the wound dressing 102 ro interior.

[0043] 在使用中,支撑元件108如图I中所示被放置在伤ロ创面“ w”内。 [0043] In use, the support member 108 as shown in FIG. I is placed within the wound ro wound "w". 微珠110定位在支撑元件108内。 Beads 110 positioned within the support member 108. 支撑在支撑元件108内的微珠110自身将布置成适应于伤ロ创面“w”的形状。 Supported within the support member 108 of beads 110 is arranged to accommodate itself to the wound injury ro "w" shape. 特别地,微珠110将迁移到伤ロ的远处区域中,即如图I中所示“隧穿”到伤口中。 In particular, beads 110 will migrate to the injured area in the distance ro, i.e., as shown in FIG I "tunnel" into the wound. 外部元件112然后被放置成与皮肤“s”接触并且可以围绕外部元件的周边用粘合剂或类似物固定到伤ロ“ W”。 Outer member 112 may then be placed outside the skin "s" around the outside and may be in contact with the element by adhesive or the like secured to the ro wound "W". 真空连接器120然后邻近外部元件122的开ロ122固定到外部元件112。 Vacuum connector 120 and outer member 122 adjacent the opening 122 ro 112 secured to the outer member. 管道106然后连接到真空连接器120。 Conduit 106 is then connected to the vacuum connector 120. 负压源104然后被启动,在伤ロ敷料102内形成压カ减小状态。 Then negative pressure source 104 is activated, the wound dressing 102 is formed in ro ka reduced pressure state. 当泵送进行时,微珠110保持它们的形状,由此形成和/或保持用于伤ロ渗出物流动的通道114。 When pumping performed, beads 110 retain their shape, thereby forming and / or maintaining a flow of wound exudate ro channel 114. 伤ロ渗出物通过微珠110(如定向箭头“d”所示)流过支撑元件108并且流出管道106。 Ro wound exudate flows the support member 110 by microbeads (e.g., directional arrows "d") 108 and an outflow conduit 106. 优选地,伤ロ渗出物沉积在与管道106和负压源104成一直线的罐或容器内。 Preferably, ro wound exudate deposited in the tank or container 106 and the conduit 104 into a negative pressure source in line.

[0044] 当典型的真空泵(例如负压源104)被启动并且被安置在特定设定点时,所述泵将开始抽空压カ直到所述泵达到设定点。 [0044] When a typical vacuum (e.g., negative pressure source 104) is activated and is arranged at a specific set point, the pump will start pressing grades evacuated until the pump reaches a set point. 在所述泵处的真空读数将保持在该水平直到设定点变化,泵被闭合,或者在系统中有克制继续达到该水平的泵送能力的显著泄漏。 Vacuum reading at the pump will stay at this level until the set point change, the pump is closed, or there is significant restraint continue to meet the pumping capacity of the leakage level in the system. 图4示出当泵被打开并且抽吸到它的设定点时在用于负压伤ロ治疗泵的真空泵测得的真空压カ与时间(t)的关系。 FIG. 4 shows the relationship ka vacuum pressure and time (t) for a negative pressure wound treatment ro measured vacuum pump when the pump is turned on and drawn into its set point. 对于用在伤口中的任何敷料(例如带有微珠110的伤ロ敷料102或包含泡沫层的现有技术的伤ロ敷料)来说泵压力读数是相同的,原因是控制泵的压カ传感器紧跟在泵之后。 For any of the dressing in the wound (e.g., beads 110 with the wound dressing 102 or injury ro prior art comprises a foam layer dressing ro) for the pump pressure reading is the same, because the pump control pressure sensor ka immediately after the pump. 在该例子中,使用本公开的敷料或现有技术的泡沫敷料将导致在泵处的相同稳态压カ读数。 In this example, using the prior art dressing or foam dressing of the present disclosure will result in a steady state of the pump at the same pressure readings ka.

[0045] 尽管对于不同敷料来说在泵处的压力读数可以是相同的,但是在伤ロ部位处的实际压カ取决于利用的敷料将是不同的。 [0045] Although different dressings for the pressure reading at the pump may be the same, but the actual pressure in the dressing at the wound site ka ro will be different depending on the use. 由于敷料有效排空的能力的差异,所以可以看到取决于使用的敷料在伤ロ部位处的实际真空水平的差异。 Due to differences in the ability of the dressing effectively emptied, so you can see the difference in the actual dressing depends on the vacuum level at the site of injury ro. 图5A和5B示出对于不同敷料材料来说敷料深度(按cm计)和在通过从顶表面(0)到伤ロ表面(X)的敷料厚度的任何点的实际压力水平之间的关系。 5A and 5B illustrates the relationship for the dressing and the depth (in cm by) the dressing material is different between the surface by any point ro (X) from the top surface (0) to the thickness of the wound dressing of the actual pressure level. 由于常规泡沫或纱布敷料在真空下塌缩,因此限制空气从伤ロ部位流动,在伤ロ部位处的压力实际上绝不会达到泵上的设定点。 Since the conventional foam or gauze dressing condensing staying in vacuo, thus limiting the air flow from the wound site ro, ro pressure at the site of injury never actually reaches the set point on the pump. 可以看出,(与常规泡沫和纱布填充敷料相比)本公开的带有微珠110的伤ロ敷料102甚至在较深的敷料深度也保持较高的真空水平,原因是微珠110是基本不塌缩的并且通过间隙保持了敞开的空气路径。 It can be seen (as compared to conventional foam padding and gauze dressing) of the present disclosure with the beads 110 wound dressing 102 ro even deeper in the depth of the dressing to maintain a high vacuum level, because the beads 110 is substantially do not collapse and maintain an open path of air through the gap.

[0046] 敷料材料之间的流动限制的差异还可能影响抽空时间和在伤ロ部位获得的真空水平。 [0046] The difference between the flow restriction of the dressing material may also affect the level of vacuum evacuation time and site of injury ro obtained. 图6示出对于本公开的敷料102和普通的泡沫敷料材料来说,在干性伤ロ(即没有伤ロ渗出物的影响)的伤ロ部位的压カ分布图。 Figure 6 shows a dressing 102 for the present disclosure and the conventional foam dressing material, in the dry wound ro (i.e., does not affect wound exudate ro) ka pressure profile ro injured site. 本公开的敷料显示了负压增加到稳态。 Dressings of the present disclosure shows a steady increase of negative pressure. 泡沫敷料和本公开的带微珠的敷料都显示了在伤ロ部位处的实际压カ低于如图5A中所示的泵设定点,然而,相信由本公开的伤ロ敷料102提供的低压カ阻力允许伤ロ负压装置比使用常规材料(例如泡沫和纱布)的伤ロ敷料更快地在伤ロ部位抽吸真空。 Foam dressing and the dressing disclosed in this band showed microbeads pump set points shown in 5A ka actual pressure is lower than at the site of injury FIG ro, however, believed that the present disclosure ro the wound dressing 102 to provide a low pressure ka resistance ro negative pressure device allowing injury than conventional materials (e.g. foams and gauze) dressing the wound ro aspiration vacuum in faster wound site ro. 最終两种敷料将获得稳定的稳态压力,具有最低流动阻カ的敷料,在该情况下本公开在伤ロ部位处达到比更具限制性的泡沫敷料高的实际真空水平。 The final two kinds of dressing and obtain a stable steady-state pressure, with the lowest resistance to flow ka dressing, in which case the present disclosure at the site of injury ro achieve more restrictive than the actual vacuum level foam dressing.

[0047] 敷料对流体流动的阻力可能由于流体加入系统中被进ー步増大。 [0047] Dressings resistance to fluid flow due to fluid may be fed into the system further ー zo large. 图7示出随着时间过去在湿性伤ロ的伤ロ部位处测得的真空水平。 Figure 7 shows a vacuum level measured over time at the site of injury ro ro was wet with injury. 示出两条线,这两条线表示本公开的带微珠110的伤ロ敷料和现有技术的泡沫敷料的真空分布图。 Shows two lines, these two lines represents the present disclosure with the beads 110 ro vacuum wound profile and the foam dressing prior art dressings. 可以看出,本公开的带微珠110的敷料102呈现出较快下降到真空压カ(如所述线的斜率所示),然后到达稳态,之后是平行于真空泵的设定点的大体上水平的路径。 As can be seen, the present disclosure dressing 102 with beads 110 showing a rapid decrease of the vacuum pressure grades (e.g., the slope of the line) and then reaches a steady state, parallel to the setpoint then the vacuum pump is of substantially path levels. 与之相比,现有技术的带泡沫的伤ロ敷料真空较慢地増大到较低真空水平(类似于图6),然后在泡沫由于来自伤ロ的渗出物而变得饱和时减小。 In contrast with the prior art foam wound dressing in vacuo slower zo ro large lower vacuum level (similar to FIG. 6), then when the foam is reduced due to the exudate from the wound becomes saturated ro . 饱和的泡沫则具有较高压降并且可以快速地超过泵保持真空的能力。 The foam having a higher saturation pressure drops quickly and may exceed the capacity of the pump to maintain a vacuum. 在伤ロ部位处的实际真空水平的减小是由于填充泡沫的小室的伤ロ流体所导致的气流限制的増大。 Great the actual vacuum level in the gas stream is reduced at the site of injury is due to trauma ro cell foam filling fluid resulting ro zo limited. 另夕卜,带微珠的敷料102还显示在伤ロ处的实际压力稍微减小,而在泡沫敷料中影响将较明显,原因在于塌缩小室的影响增加。 Another Bu Xi with microbeads dressing 102 also displays the actual pressure at the wound ro slightly reduced, but the foam will obviously affect the dressing, due to the effect of increasing the collapse reduction chamber. 相信该影响导致压力(在伤ロ部位处的真空损失)的逐渐增大,这与负压伤ロ治疗的益处背道而驰。 We believe that the influence resulting in pressure (vacuum loss at the site of injury ro) gradually increases, which is a negative pressure wound therapy benefit ro contrary. [0048] 图8A和SB示出在遂穿伤ロ的情况下从敷料的顶表面(0)到伤ロ的底部(X)(按cm计)的真空水平的下降可能比5A和5B中所述的更加严重。 [0048] FIGS. 8A and SB shows a decrease from the top surface of the dressing (0) to the bottom of injury ro of (X) (by in cm) of the vacuum level can be lower than 5A and 5B as in the case of tunneling injury ro of mentioned more serious. 当负压施加到伤ロ时,遂穿伤ロ的窄部分(a)可以由于真空压カ和传统泡沫敷料的塌缩被牵拉闭合。 When a negative pressure is applied to the wound ro, ro tunneling injury narrow portion (a) can be the vacuum pressure and the traditional grades collapsed foam dressing is pulled closed. 如果是这种情况,压カ分布图将从敷料表面稳定地减小到夹点,然后下降接近伤ロ的遂穿部分内部的大气压。 If this is the case, the pressure distribution from the surface of the dressing ka is stably reduced to the pinch point, and then decreases near the injury ro tunneling portion of the internal atmospheric pressure. 当使用本公开的带微珠的敷料时,微珠110将不在负压下塌缩,因此在间隙中保持减轻压カ的路径,并且在包括隧道的整个伤口上获得负压的治疗水平。 When using microbeads of the present disclosure with a dressing, beads 110 will not collapse under negative pressure, and therefore reduce the gap holding pressure ka path, and therapeutic levels of negative pressure is obtained over the entire wound including tunnel.

[0049] 同样重要的是注意用于敷料中的微珠110的尺寸将影响间隙中的平均孔尺寸,微珠越大间隙越大。 [0049] It is also important to note that the size of the dressing beads 110 will affect the average pore size of the gap, the greater the gap microbeads. 平均孔尺寸与空气或流体流过敷料的限制直接相关。 The average pore size is directly related to the air or fluid flowing through the restricted dressing. 图9示出如果使用大约2mm级的较大微珠,抽空时间将比使用具有较小的平均孔尺寸和较大的流动限制的较小微珠(例如直径为0. 5mm)短。 FIG 9 shows that if the level using about 2mm larger beads, evacuation time than having a smaller average pore size of the smaller beads and the larger flow restriction (e.g., a diameter of 0. 5mm) short.

[0050] 现在參考图10,示出本公开的可供选择的实施例。 [0050] Referring now to Figure 10, the present embodiment illustrates an alternative embodiment of the disclosure. 根据该实施例,支撑元件采用容纳微珠Iio的封闭元件或囊袋124的形式。 According to this embodiment, the support element takes the form of the closure member or the pouch 124 receiving the microbeads Iio. 囊袋124可以包括出入开ロ以允许微珠110定位在其中。 Bladder 124 may comprise access opening to permit ro beads 110 positioned therein. 可供选择地,囊袋124可以具有上文与外部元件112相关的所述类型的出入门。 Alternatively, the balloon 124 may have an associated entry 112 of the type described above with an external element. 进ー步可供选择地,囊袋124可以被密封,并且微珠110被预先包装在其中。 Step into ー Alternatively, the bladder 124 may be sealed and the beads 110 are pre-packaged therein. 囊袋124可以设置成片材或卷,以允许伤ロ敷料100的尺寸设定成适合不同形状、深度等的伤ロ。 Balloon 124 may be provided in sheet or roll, to allow the wound dressing 100 ro size set to fit different shapes and depth of injury ro. 所述卷可以具有区分单个囊袋的穿孔,所述囊袋可以从卷上分离并且因此确定尺寸。 The perforations may have a volume distinguish individual pouch, the pouch may be separated from the roll and thus dimensioned. 通过设置微珠110储存在其中的封闭物,囊袋124便于微珠110的操作。 By providing the beads stored therein closure 110, the balloon 124 of beads 110 facilitates operation. 微珠110能够在囊袋124内移动以在愈合期间和/或负压的循环应用期间重新调整。 Beads 110 can be moved to and / or during a re-adjustment of the cycle of negative pressure applied within the bladder 124 during healing.

[0051] 图11示出ー个可供选择的实施例,其中多个封闭囊袋124设置用于接收微珠110,并且可定位在伤ロ创面“w”内。 [0051] FIG. 11 shows an alternative embodiment ー embodiment, wherein the plurality of closed pockets 124 is provided for receiving the beads 110, and may be positioned within the wound ro wound "w". 数量増加的囊袋124可以便于微珠110的放置和去除。 To increase in the number of the bladder 124 may facilitate placement and removal of the beads 110.

[0052] 图12公开了本公开的伤ロ敷料的ー个可供选择的实施例。 [0052] FIG. 12 of the present disclosure discloses a wound dressing ro ー one alternative embodiment. 根据该实施例,微珠110穿在细长元件、缝线或细绳126上,因此防止微珠110在应用于伤ロ敷料102中之前变松或者当布置在伤ロ创面“w”中时松动(图10)。 According to this embodiment, beads 110 threaded onto the elongated member, the suture or string 126, thereby preventing the beads 110 are applied to the wound dressing 102 prior ro ro loosened or when disposed in the wound when the wound "w" loose (FIG. 10). 带微珠110的细长元件126可以添加到伤ロ创面“w”并且可定位在支撑元件108内。 The elongated member 110 with bead 126 can be added to the wound ro wound "w" and may be positioned within the support member 108. 可以想到的是,带微珠110的细长元件126可以被切割以适合特定的伤ロ创面“W”。 It is contemplated that the elongated member 110 with beads 126 may be cut to suit a particular wound ro wound "W". 细长元件126可以由生物可吸收的材料形成,或者可供选择地可以由不可吸收的材料形成。 The elongated member 126 may be formed of a bioabsorbable material, or alternatively may be formed from non-absorbable material. 合适的材料包括来自Tyco Healthcare GroupLP下属的US Surgical的P0LYS0RB™缝线、合成聚酯、肠线或者包括蚕丝或尼龙的不可吸收的材料。 Suitable materials include P0LYS0RB ™ suture, synthetic polyester, Tyco Healthcare GroupLP gut from US Surgical under the nonabsorbable material comprises or silk or nylon.

[0053] 现在參考图13-15,示出本公开的伤ロ敷料系统的另一可供选择的实施例。 [0053] Referring now to FIGS. 13-15, there is shown an embodiment of the present disclosure wound dressing ro another alternative system. 伤ロ敷料系统200包括伤ロ敷料202,所述伤ロ敷料具有采用片材204形式的支撑元件以及粘结到片材204的微珠206 (图14和15)。 System 200 includes a wound dressing ro ro wound dressing 202, the dressing having a wound ro support member 204 employed in the form of a sheet and bonded to the beads 204 of the sheet 206 (FIGS. 14 and 15). 片材204优选地由硅树脂形成,尽管还可以想到其它材料。 The sheet 204 is preferably formed of silicone, although other materials are also contemplated. 微珠206可以在制造期间被ホ旲制到片材204上或者随后被粘结到片材204上。ホ Dae beads 206 may be made during manufacturing or to the sheet 204 is then bonded to the sheet 204. 片材204可以是可透液体、蒸汽等的,或者可以具有穿孔以允许空气和流体穿过伤ロ创面“w”进入管道。 The sheet 204 may be a liquid permeable, vapor or the like, or may have perforations to allow air and fluid to pass through injury ro wound "w" into the conduit. 片材204是基本柔性的并且构造成基本适应于如图13中所示的伤ロ创面“W”。 The sheet 204 is substantially flexible and is configured to accommodate substantially as shown in FIG. 13 ro injury wound "W". 微珠206和片材204可以包含抗菌剂或抗感染剂,例如银或PHMB。 Bead 206 and the sheet 204 may comprise an antimicrobial or anti-infective agents, such as silver or PHMB.

[0054] 伤ロ敷料202还可以包括吸收元件208。 [0054] ro wound dressing 202 may further include an absorbent element 208. 吸收元件208可以由选自下列材料组成的组的材料制造:泡沫、海绵、无纺复合织物、纤维素织物、超吸收性聚合物以及它们的组合物。 Absorbing element 208 may be of a material selected from the group consisting of the following materials: foam, sponge, nonwoven composite fabrics, cellulosic fabrics, super absorbent polymers, and combinations thereof. 吸收元件208用于吸收和俘获伤ロ流体和渗出物。 The absorbent member 208 for absorbing and trapping injuries ro fluids and exudates. 用作吸收元件208的典型材料包括在商标KERLIX™下由TycoHealthcare下属的Kendall Corp.公司销售的抗微生物敷料。 Typical materials for use as the absorbent element comprises 208 KERLIX ™ under the trademark of the Kendall Corp. TycoHealthcare under antimicrobial dressing sold. 本领域的技术人员将认识到吸收元件208可以形成任何合适的形状。 Those skilled in the art will recognize that the absorbent member 208 may be formed in any suitable shape. 关于形状的唯一要求是吸收元件208适合适应于伤ロ的特定形状。 The only requirement for the shape of the absorbent member 208 is adapted to accommodate the particular shape of the injury ro.

[0055] 伤ロ敷料进ー步包括外部元件210,该外部元件基本类似于上文与图I的实施例相关的所述外部元件112。 [0055] ro wound dressing further comprises an outer ー intake element 210, the outer element substantially similar to the embodiment described above and Fig. I related embodiment the outer member 112.

[0056] 现在參考图16,示出本公开伤ロ敷料系统的另一可供选择的实施例。 [0056] Referring now to Figure 16, illustrate the present disclosure ro wound dressing system further alternative embodiment. 根据该实施例,支撑元件和微珠用下元件或框架元件300替代。 According to this embodiment, the support member and the lower member or microbeads frame member 300 instead. 框架元件300优选地是限定多边形网格支撑物的蜂窝结构,所述蜂窝结构具有与延伸通过其中的间隔开室304互连的一系列壁302。 Frame member 300 preferably defines a support polygon mesh honeycomb structure, the honeycomb structure having spaced apart therein extending chamber 304 interconnected by a series of walls 302. 框架元件300是刚性的并且在负压カ下将不会塌缩,同时间隔小室304允许流体和空气流过其中。 The frame member 300 is rigid and will not collapse under negative pressure ka, while being spaced a small air chamber 304 and allow fluid flow therethrough. 框架元件300优选地由硅树脂或另外合适的生物相容材料制造。 The frame member 300 is preferably made of silicone or another suitable biocompatible material. 框架元件300优选地被模制到特定的网格框架中。 The frame member 300 is preferably molded into a particular grid framework. 小室304在构造上可以为六边形、正方形、三角形甚至圆形。 Chamber 304 can be configured in a hexagonal, square, triangular and even circular. 如上文所述,抗菌剂或抗感染剂(例如银或PHMB)可以布置在小室304内或者包含在框架元件300的框架的表面内。 As described above, antibacterial or anti-infective agents (such as silver or PHMB) may be disposed within the chamber 304, or contained within the surface of the frame 300 of the frame member.

[0057] 尽管示出和描述了本公开,但并非想要限制所示的细节,原因是可以在不以任何方式脱离本公开的精神的情况下进行各种修改和替换。 [0057] Although shown and described the present disclosure, but not intended to limited to the details shown, because various modifications and substitutions can be made without departing from the spirit of the disclosure in any way. 例如,微珠不需要是圆形的;它们可以为带状、多边形、椭圆形等。 For example, the beads need not be circular; they may be a belt, polygonal, oval and the like. 照这样,本领域的技术人员可以仅仅使用例行经验想到这里公开的本发明的进ー步修改和等效物,并且我们相信所有这样的修改和等效物在由以下权利要求所限定的公开的精神和范围内。 As such, those skilled in the art can think of using only routine into ー experience further modifications and equivalents of the invention herein disclosed, and we believe that all such modifications and equivalents of the following claims as defined by the disclosure within the spirit and scope.

Claims (24)

1. 一种伤口敷料系统,该伤口敷料系统包括: 可透流体的支撑元件,所述支撑元件构造用于定位在伤口内并且适于大体上适应于伤口的形态,并且允许来自伤口的渗出物通过所述支撑元件; 由所述支撑元件支撑的多个微珠,所述微珠具有足够的刚性以基本保持它们各自的形状,由此便于渗出物通过相邻微珠之间限定的空隙,至少一些微珠具有通过所述微珠的孔; 外部元件,该外部元件适于定位在伤口上以基本封闭所述微珠;和管道,该管道用于将减小的压力供给伤口。 1. A wound dressing system, the wound dressing system comprising: a fluid permeable support member, the support member is configured for positioning within the wound and adapted to substantially adapted to form a wound, exudate from the wound and allow purified by the support element; a plurality of supporting elements of the supporting beads, the beads having sufficient rigidity to substantially retain their respective shapes, thereby facilitating exudates defined between adjacent beads by void, at least some of the beads have a hole through the beads; outer member, the outer member adapted to be positioned over a wound to substantially enclose the beads; and a duct for supplying reduced pressure to the wound.
2.根据权利要求I所述的伤口敷料系统,其中所述微珠包括玻璃。 The wound dressing system of claim I, wherein the beads comprise glass.
3.根据权利要求I所述的伤口敷料系统,其中所述微珠包括丙烯酸酯。 The wound dressing system of claim I, wherein the beads comprise acrylate.
4.根据权利要求I所述的伤口敷料系统,其中所述微珠包括聚合材料。 The wound dressing according to claim system of claim I, wherein the beads comprise a polymeric material.
5.根据权利要求I所述的伤口敷料系统,其中至少一些微珠包括药剂的外层。 5. The wound dressing system of claim I, wherein at least some of the beads comprise an outer layer of an agent.
6.根据权利要求I所述的伤口敷料系统,其中多个微珠中的每一个具有通过所述微珠的孔。 6. The wound dressing system of claim I, wherein each of the plurality of microbeads having a hole through the beads.
7.根据权利要求I所述的伤口敷料系统,其中至少一些微珠包括布置在所述孔内的药剂。 The wound dressing system of claim I, wherein at least some of the beads comprise an agent disposed in the bore.
8.根据权利要求I所述的伤口敷料系统,其中多个微珠中的至少一些沿着细长元件、细绳和缝线中的一个穿设。 8. The wound dressing system of claim I, wherein at least some of the plurality of beads along the elongated member, and the string suture in a bored.
9.根据权利要求I所述的伤口敷料系统,其中所述微珠安装到所述支撑元件。 9. The wound dressing system of claim I, wherein the beads mounted to the support member.
10.根据权利要求I所述的伤口敷料系统,其中所述支撑元件包括织物材料。 The wound dressing according to claim 10. The system of claim I, wherein said support member comprises a fabric material.
11.根据权利要求I所述的伤口敷料系统,其中所述支撑元件包括聚合材料。 11. The wound dressing system of claim I, wherein said support member comprises a polymeric material.
12.根据权利要求I所述的伤口敷料系统,其中所述外部元件适于形成围绕伤口的基本不透液体的密封件。 12. The wound dressing system of claim I, wherein the outer member is adapted to be formed around the wound member is substantially liquid tight seal.
13.根据权利要求I所述的伤口敷料系统,其中所述外部元件包括半透性材料。 13. The wound dressing system of claim I, wherein said outer member comprises a semipermeable material.
14.根据权利要求I所述的伤口敷料系统,所述伤口敷料系统进一步包括与所述管道流体连通的负压源。 The wound dressing according to claim I of the system, said system further comprising a wound dressing and the negative pressure source conduit in fluid communication.
15.根据权利要求14所述的伤口敷料系统,其中所述负压源包括真空泵。 15. A wound dressing system according to claim 14, wherein said negative pressure source comprises a vacuum pump.
16.根据权利要求I所述的伤口敷料系统,其中所述支撑元件是囊袋,所述囊袋容纳所述微珠。 16. The wound dressing system of claim I, wherein said support element is a bladder, said bladder receiving the beads.
17. 一种伤口敷料系统,该伤口敷料系统包括: 可透流体的封闭囊袋,所述封闭囊袋构造用于定位在伤口内并且适于允许来自伤口的渗出物通过所述封闭囊袋; 布置在所述封闭囊袋内的多个微珠,所述微珠具有足够的刚性以基本保持它们各自的形状,由此便于渗出物通过相邻微珠之间限定的空隙,至少一些微珠沿着细绳或缝线连接; 外部元件,该外部元件适于定位在伤口上以基本封闭所述微珠;和负压装置,该负压装置用于将减小的压力供给伤口。 17. A wound dressing system, the wound dressing system comprising: a fluid-tight closure pockets, the closure pockets configured for positioning within the wound and adapted to allow the exudate from the wound through the closed pockets ; a plurality of beads disposed in the closed sachet, the beads having sufficient rigidity to substantially retain their respective shapes, thereby facilitating exudates from passing through the gap defined between the adjacent beads, at least some of the connected along a suture or string beads; outer member, the outer member adapted to be positioned over a wound to substantially enclose the beads; and suction means, the suction means for supplying reduced pressure to the wound.
18. 一种伤口敷料系统,该伤口敷料系统包括: 框架,其尺寸设定成用于定位在伤口创面内,所述框架包括限定间隔小室的一系列互连壁,所述小室具有足够的刚性以在减小的压力下基本保持它们的初始构造,并且尺寸设定成允许伤口渗出物通过其中;和管道,其用于将减小的压力供给伤口创面。 18. A wound dressing system, the wound dressing system comprising: a frame sized to be positioned within the wound bed for the frame comprising a series of interconnected walls defining spaced small chamber, said chamber having sufficient rigidity to substantially maintain the reduced pressure at their original configuration and dimensioned to permit wound exudate therethrough; and a conduit for supplying reduced pressure to the wound bed.
19.根据权利要求18所述的伤口敷料系统,其中所述小室中的至少一个限定基本为多边形的形状。 19. A wound dressing system according to claim 18, wherein said at least one chamber defining a substantially polygonal shape.
20.根据权利要求18所述的伤口敷料系统,其中所述框架包括硅。 20. A wound dressing system according to claim 18, wherein said frame comprises silicon.
21.根据权利要求I所述的伤口敷料系统,其中至少一些微珠包括选自下列物质的组中的至少一种物质:抗菌剂、生长因子、药剂、抗生素、止痛剂、愈合因子、以及营养物。 21. The wound dressing system of claim I, wherein at least some of the following materials selected from the group comprising beads of at least one substance: antimicrobial agents, growth factors, medicaments, antibiotics, analgesics, healing factors, and nutrients thereof.
22.根据权利要求21所述的伤口敷料系统,其中所述愈合因子是维生素。 22. A wound dressing system according to claim 21, wherein said healing factor is a vitamin.
23.根据权利要求I所述的伤口敷料系统,其中至少一些所述微珠包括生物可吸收的聚合物。 23. The wound dressing system of claim I, wherein at least some of said beads comprises a bioabsorbable polymer.
24.根据权利要求23所述的伤口敷料系统,其中所述生物可吸收的聚合物选自由下列物质组成的组:聚交酯(PLA)、聚乙交酯(PGA)、壳聚糖、聚环氧乙烷(PEO)和聚乙二醇(PEG)。 24. The wound dressing system according to claim 23, wherein said bioabsorbable polymer is selected from the group consisting of: polylactide (PLA), polyglycolide (PGA), chitosan, poly ethylene oxide (PEO) and polyethylene glycol (PEG).
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